NCT01819896

Brief Summary

Over the past year smartphones have developed from a niche product to a commoditized product and are now squeezing classic mobile phones out of market. According to a survey a quarter of the German population is making use of a smartphone at present. An interference between smartphones and the functionality of pacemakers or implantable defibrillators is rather unlikely but cannot entirely be excluded. A systematic study regarding a possible interference between smartphones and modern pacemaker- and ICD-system with a better shielding against external influence has not taken place so far. In this study the investigators intend to investigate any interference between different smartphones produced by different manufacturers and diverse cardiovascular implanted electronic devices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

February 28, 2013

Last Update Submit

February 12, 2015

Conditions

Recipients of Implantable Pacemakers or Defibrillators

Outcome Measures

Primary Outcomes (1)

  • Interference of smartphones with cardiac implantable electronic devices

    Interference testing will be performed during routine follow-up of pacemakers or defibrillators and potential interference will be recorded by ECG.

    acute study (no follow-up)

Study Arms (1)

pacemakers and defibrillators

Drug: Pacemaker and defibrillator

Interventions

Pacemaker and defibrillatorDRUG
pacemakers and defibrillators

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recipients of implantable pacemakers or defibrillators

You may qualify if:

  • Presence of an implantable pacemaker or defibrillator

You may not qualify if:

  • Lead malfunction which can not reprogrammed
  • Battery depletion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

München, Bavaria, 80636, Germany

Location

MeSH Terms

Interventions

Defibrillators

Intervention Hierarchy (Ancestors)

ElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 28, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2013

Study Completion

January 1, 2015

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

DE(1)